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Multi-Center Prospective Study to Compare Single-incision Versus Conventional Laparoscopic Appendectomy

Status Approved

  • First Submitted Date

    2020/03/17

  • Registered Date

    2020/05/21

  • Last Updated Date

    2020/05/04

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005048
    Unique Protocol ID DGIRB-2019-12-001
    Public/Brief Title Single-incision Versus Conventional Laparoscopic Appendectomy
    Scientific Title Multi-Center Prospective Study to Compare Single-incision Versus Conventional Laparoscopic Appendectomy
    Acronym SCAR
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number DGIRB-2019-12-001-001
    Approval Date 2020-02-27
    Institutional Review Board Name Daegu Joint institutional Review Board
    Institutional Review Board Address Room# 316, Kyungpook National University School of Medicine, 680 Gukchaebosang-ro, Jung-gu, Daegu, Republic of Korea 41944
    Institutional Review Board Telephone 053-623-8490
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Sung Uk Bae
    Title Assistant professor
    Telephone +82-53-258-7884
    Affiliation Keimyung University Dongsan Hospital
    Address 1095 Dalgubeol-daero, Dalseo-gu
    Contact Person for Public Queries
    Name Sung Uk Bae
    Title Assistant professor
    Telephone +82-53-258-7884
    Affiliation Keimyung University Dongsan Hospital
    Address 1095 Dalgubeol-daero, Dalseo-gu
    Contact Person for Updating Information
    Name Sung Uk Bae
    Title Assistant professor
    Telephone +82-53-258-7884
    Affiliation Keimyung University Dongsan Hospital
    Address 1095 Dalgubeol-daero, Dalseo-gu
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 3
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-01 Anticipated
    Target Number of Participant 120
    Primary Completion Date 2021-06-30 , Anticipated
    Study Completion Date 2021-07-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Keimyung University Dongsan Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-01 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Yeongnam University Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-01 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Daegu Catholic University Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-01 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name DALIM MEDICAL CORPORATION
    Organization Type Pharmaceutical Company
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Keimyung University Dongsan Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    As minimally invasive surgery has rapidly developed in recent years, minimizing surgical trauma and improving cosmetic outcomes, single-port laparoscopic surgery was introduced. The aim of our study is to compare outcomes between single-port and multi-port laparoscopic appendectomy for acute appendicitis and to evaluate the feasibility of single-port laparoscopic appendectomy as a standard procedure. After obtaining the consent of the study, inclusion and exclusion criteria are checked, and a single-port laparoscopic surgery and a traditional multi-port laparoscopic surgery are determined by randomly assigning a method. 
    1) Baseline demographics of each participants such as age, height, body weight, preoperative white blood cell count and C-reactive protein level etc. will be obtained before surgery.
    2) Intraoperative findings (e.g. operative time, conversion to open or conventional multi-port laparoscopic surgery, vascular or organ injury during trocar insertion, incision length will be recorded.
    3) Visual Analog Scale will be obtained at 6 hours after end of surgery, postoperative day 1 and 2 in the morning.
    4) International Pain Outcomes questionnaire  will be obtained at postoperative day one.
    5) Patient and observer scar assessment scale and body image questionnaires will be obtained 6 weeks after surgery in the outpatient clinic. If the participant were not visit the day, telephone interview will be permit for completion of the survey.
    6) Postoperative outcomes including hospital stay, complication, re-admission within 30 days after operation will be also collected.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-control
    Time Perspective Prospective  
    Target Number of Participant 120
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    Single-port laparoscopic group

    Cohort/Group Description

    For the group who undergo a single-port laparoscopic appendectomy via single incision at umbilical area, the surgical results, postoperative complications, and short-term clinical outcomes after surgery are observed.
    Cohort/
    Group 2

    Cohort/Group Label

    Conventional laparoscopic group

    Cohort/Group Description

    For the group who undergo a multi-port laparoscopic appendectomy via 3-port trocar insertion at peri-umbilical, left lower quadrant and supra-pubic site, the surgical results, postoperative complications, and short-term clinical outcomes after surgery are observed.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Patients ≤75 years diagnosed acute appendicitis who will receive laparoscopic appendectomy
    Sampling Method
    The target sample size will be 120 participants by probability sampling, as this will provide 80% power at the 2.5% (2-sided) level of significance to detect a 3-points differences in Patient and Observer Scar Assessment (POSA) score at 6 weeks after surgery between the SILA group and the control group, with allowance for 10% attrition.
    Condition(s)/Problem(s) * (K00-K93)Diseases of the digestive system 
       (K35.8)Acute appendicitis, other and unspecified 

    Appendicitis, Appendectomy, Laparoscopy, Wounds and Injuries, Pain
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~75Year

    Description

    1) Patients aged ≥19 and ≤75 years 
    2) Patients diagnosed acute appendicitis who will receive laparoscopic appendectomy
    Exclusion Criteria
    1) patients who is suspected perforated appendicitis
    2) patients with pan-peritonitis symptom
    3) patients who has previous major abdominal surgery except cholecystectomy, Cesarean delivery
    4) patients who have an inability to express himself/herself due to conditions such as dementia and intellectual disabilities
    5) patients who have chronic pain need to take analgesics
    6) pregnancy
    7) patients diagnosed as other disease
    8) patients who have severe medical disease such as pulmonary, cardiovascular, hepatic, or renal insufficiency
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Patient and Observer Scar Assessment
    Timepoint
    6 weeks after surgery
    Secondary Outcome(s) 1
    Outcome
    international Pain Outcomes questionnaire
    Timepoint
    postoperative day 1
    Secondary Outcome(s) 2
    Outcome
    Visual Analogue Scale
    Timepoint
    6 hours after end of surgery, postoperative day 1 and 2
    Secondary Outcome(s) 3
    Outcome
    Body image Questionnaire
    Timepoint
    6 weeks after surgery
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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